Medical device, and the methods of using same

ABSTRACT

A medical device is provided for insertion into a cavity of a patient to visual the internal membranes of the patient. The medical device can be an endotracheal tube, a suction tube, a bronchoscope, a tube changer, an esophageal tube, an intubating tube, an esophageal tube in combination with a separate intubating tube, a device for manipulating the position of the epiglottis of the patient, a stylet, or a tube insertable into the vagina of the patient. The medical device has a camera lumen having a sealed window at one end thereof attached thereto, and a separate camera which is insertable into the camera lumen and is removable from the camera lumen. The camera is used to monitor the internal membranes of the patient during the medical procedure.

This application is a continuation-in-part application of U.S. Ser. No.13/486,549, filed on Jun. 1, 2012, the disclosure of which isincorporated in its entirety. This application claims the domesticbenefit of U.S. Ser. No. 61/674,924, filed on Jul. 24, 2012, thedisclosure of which is incorporated in its entirety.

FIELD OF THE INVENTION

The present invention relates to a medical device for allowing a medicalprofessional to see the internal membranes of a patient during a medicalprocedure.

BACKGROUND OF THE INVENTION

An example of a medical device which medical professionals use to seethe internal membranes of a patient is a laryngeal mask airway. Alaryngeal mask airway is used to ventilate and to supply anesthetic to apatient during surgery. A laryngeal mask airway is different than anendotracheal tube in that the laryngeal mask airway is positioned in thethroat of the patient proximally of the vocal folds, while anendotracheal tube is passed through the vocal folds and is positioned inthe patient's trachea.

Laryngeal mask airways of the prior art generally have a tube openinginto the center of a generally elliptical dome. The tube is generallystraight, but can flex to assume a curved shape. A cuff, which may beinflatable, is sometimes attached to the perimeter of the dome.

In use, the medical professional inserts the laryngeal mask airway intothe mouth of the patient. The open tube allows the patient to breathe onhis/her own during insertion. The tube can also be connected to aventilator to provide assisted breathing to the patient. For insertion,the cuff (if provided), the dome and the tube slide against the hardpalate and then against the soft palate and into the pharynx of thepatient. This procedure is performed blindly and only by feel whichcomes from experience in performing the procedure. Trauma to the patientmay occur when placing the laryngeal mask airway as a result of thelaryngeal mask airway attempting to conform to a curved position in thepharynx. When properly positioned in the hypo-pharynx, the proximal endof the cuff seats against the epiglottis pushing it toward the tongue ofthe patient and the distal end of the cuff seats in the esophagus. Attimes, the cuff may be positioned such that the epiglottis is pusheddownwardly and may at least partially block the tube opening. This isnot a desirable result as the blocking by the epiglottis can causeproblems with the airflow through the laryngeal mask airway. Inaddition, inappropriate sizing and differences in the anatomy ofpatients may also impair the proper positioning of the laryngeal maskairway. Since the insertion is performed blindly, the medicalprofessional will not know if proper placement of the laryngeal maskairway has occurred. After positioning the laryngeal mask airway, theinflatable cuff (if provided) is inflated and the patient's esophagus isblocked by the cuff. The medical professional will listen for breathsounds and ascertain end tidal CO₂ gases from the patient to verifyproper positioning of the laryngeal mask airway.

If the medical professional needs to insert an endotracheal tube intothe patient, the endotracheal tube can be inserted through the tube ofthe laryngeal mask airway to intubate the patient. If the epiglottis isat least partially blocking the opening in the tube, this intubation maybe difficult. In addition, the glottis opening quite often does notalign with the tube opening which can make this blind insertiondifficult and may result in trauma to the laryngeal inlet.

A medical device is provided herein which provides improvements toexisting laryngeal mask airways and which overcomes the disadvantagespresented by the prior art. Other features and advantages will becomeapparent upon a reading of the attached specification, in combinationwith a study of the drawings.

SUMMARY OF THE INVENTION

A medical device is provided for insertion into a cavity of a patient tovisual the internal membranes of the patient. The medical device can bean endotracheal tube, a suction tube, a bronchoscope, a tube changer, anesophageal tube, an intubating tube, an esophageal tube in combinationwith a separate intubating tube, a device for manipulating the positionof the epiglottis of the patient, a stylet, or a tube insertable intothe vagina of the patient. The medical device has a camera lumen havinga sealed window at one end thereof attached thereto, and a separatecamera which is insertable into the camera lumen and is removable fromthe camera lumen. The camera is used to monitor the internal membranesof the patient during the medical procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The organization and manner of the structure and operation of theinvention, together with further objects and advantages thereof, maybest be understood by reference to the following description, taken inconnection with the accompanying drawings, wherein like referencenumerals identify like elements in which:

FIG. 1 is a perspective view of a medical device which incorporates thefeatures of the present invention, the medical device being insertedinto a patient, and shown with an endotracheal tube and a ventilatorwhich are capable of being used with the medical device;

FIG. 2 is a perspective view of the medical device of FIG. 1;

FIG. 3 is an alternate perspective view of the medical device of FIG. 1;

FIG. 4 is yet another alternate perspective view of the medical deviceof FIG. 1;

FIG. 5 is a side elevation view of the medical device of FIG. 1;

FIG. 6 is a side elevation view of the medical device of FIG. 1 insertedinto a patient;

FIG. 7 is a side elevation view of the medical device of FIG. 1 insertedinto a patient, and shown with an endotracheal tube inserted therein;

FIG. 8 is a schematic view of the medical device of FIG. 1;

FIG. 9 is a perspective view of an alternate medical device whichincorporates the features of the present invention;

FIG. 9A is a perspective view of a modification to the medical device ofFIG. 9;

FIG. 10 is a schematic view of the medical device of FIG. 9;

FIG. 11 is a schematic of a control system for use with the medicaldevices shown in the drawings;

FIG. 12 is a perspective view of an airway assist device whichincorporates the features of the present invention for use with themedical devices of FIGS. 1 and 9 and 10;

FIG. 13 is a side elevation view of the airway assist device of FIG. 12;

FIG. 14 is a perspective view of the lumens which form part of theairway assist device of FIG. 12;

FIGS. 15 and 16 are side elevation views of the airway assist device ofFIG. 12 inserted into a patient;

FIG. 17 is a perspective view of an alternate airway assist device whichincorporates the features of the present invention for use with themedical devices of FIGS. 1 and 9/10;

FIG. 18 is a perspective view of the airway assist device of FIG. 17with a medical device mounted therein;

FIGS. 19 and 20 are side elevation views of the airway assist device ofFIG. 17 with a medical device mounted therein;

FIG. 21 is a perspective view of another medical device whichincorporates the features of the present invention inserted into apatient;

FIG. 22 is a side elevation view of the medical device of FIG. 21;

FIG. 23 is an end elevation view of the medical device of FIG. 21;

FIG. 24 is alternate perspective view of the medical device of FIG. 21:

FIGS. 25A-25E are side elevation views of the medical device of FIG. 21being inserted into a patient, and being used with a stylet and anendotracheal tube;

FIGS. 26 and 27 are perspective views of an alternate medical devicewhich incorporates the features of the present invention;

FIG. 28 is a side elevation view of the medical device of FIGS. 26 and27;

FIGS. 29 and 30 are perspective views of the medical device of FIGS.26-28, with an endotracheal tube being shown for use therewith;

FIGS. 31A and 31B are side elevation views of the medical device ofFIGS. 26-28 being inserted into a patient, and being used with anendotracheal tube;

FIG. 32 is a perspective view of another medical device whichincorporates the features of the present invention;

FIG. 33 is a perspective view of yet another medical device whichincorporates the features of the present invention;

FIG. 34 is a perspective view of the medical device of FIG. 33 in analternate position;

FIG. 35 is a cross-sectional view of the medical device of FIG. 33;

FIG. 36 is a perspective view of another medical device whichincorporates the features of the present invention;

FIGS. 37A and 37B show the medical device of FIG. 36 in use in apatient;

FIGS. 38-39C show perspective views of a further medical device whichincorporates the features of the present invention;

FIG. 40 shows a perspective view of yet another medical device whichincorporates the features of the present invention:

FIG. 41 shows a perspective view of yet another medical device whichincorporates the features of the present invention;

FIG. 42 shows a perspective view of another medical device whichincorporates the features of the present invention;

FIGS. 43 and 44 show perspective views of yet a further medical devicewhich incorporates the features of the present invention:

FIG. 45 shows a perspective view of another medical device whichincorporates the features of the present invention; and

FIG. 46 shows a perspective view of a tool which can be used with themedical device of FIG. 45.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

While the invention may be susceptible to embodiment in different forms,there is shown in the drawings, and herein will be described in detail,a specific embodiment with the understanding that the present disclosureis to be considered an exemplification of the principles of theinvention, and is not intended to limit the invention to that asillustrated and described herein. Therefore, unless otherwise noted,features disclosed herein may be combined together to form additionalcombinations that were not otherwise shown for purposes of brevity.

FIGS. 1-8 show a first embodiment of a medical device 20 and FIGS. 9/9Aand 10 show a second embodiment of a medical device 120. The medicaldevice 20, 120 is inserted into the throat of a patient 22 to open theairway to allow the patient 22 to breathe on his/her own, to allow thepatient 22 to breathe with ventilation via a ventilator 23 or forintubating the patient 22 with an endotracheal tube 24. Each medicaldevice 20, 120 is formed of a dual-tube design which includes aventilating tube 26, 126 and an intubating tube 28, 128 which areconnected to a dome 30, 130. A cuff 32, 132, which may inflatable, isattached to the perimeter 31, 131 of the dome 30, 130. While theinflatable cuff 32, 132 is shown and described herein, the inflatablecuff 32, 132 is not necessary, or it may be formed of rubber provided atthe end of the tubes 26, 126, 28, 128. The dual-tube design provides theventilating tube 26, 126 for allowing the patient to breathe on his/herown or for ventilation, and the intubating tube 28, 128 for intubationof the patient 22.

Each medical device 20, 120 includes a camera lumen 58 which is formedby a small diameter flexible plastic tube. The camera lumen 58 has aproximal end and an opposite distal end and a central passagewaytherethrough. The distal end of the camera lumen 58 has a clear window60 which is sealed to the camera lumen 58 to close the end of thecentral passageway. As a result, the camera lumen 58/window 60 areimpervious to gases/fluids such that entry of fluids and other matterinto the camera lumen 58 is prevented. A pair of LED lights 62 may beformed in the wall of the camera lumen 58 on opposite sides of thewindow 60. If LED lights 62 are provided in the camera lumen, wires aremolded into the camera lumen 58 and extend from the proximal end thereoffor connection to a suitable power source. A non-disposable camera 66can be easily slid into and removed from the scaled camera lumen58/window 60 combination. Instead of providing separate LED lights 62 inthe camera lumen 58, the camera 66 and LED lights 62 (or other source oflighting, including a camera with its own built-in lighting) can beincorporated into a single non-disposable device which is insertable andremoveable from the camera lumen 58.

Each medical device 20, 120 includes a transmission lumen 68 fortransmitting breath and heartbeat sounds from the patient 22 to themedical professional. The transmission lumen 68 is formed by asmall-diameter flexible plastic tube having a central passageway and aseries of perforations 70 at its distal end. The perforations 70 arecovered by a thin gauge plastic cap 72. When the medical device 20, 120is seated in the throat of the patient 22, the distal end of thetransmission lumen 68 is positioned closest to the esophagus 80 whichenables breath and heartbeat sounds to be easily transmitted through theperforations 70 and along the length of the transmission lumen 68 to themedical professional monitoring the patient 22.

Attention is invited to the first embodiment of the medical device 20shown in FIGS. 1-8 which shows the specifics of the dual-tube design.[0006] Each tube 26, 28 is formed from a cylindrical wall 36, 38 havinga proximal open inlet 36 a, 38 a (at the end closest to the medicalprofessional), an opposite distal open outlet 36 b, 38 b (at the endfurthest away from the medical professional during use of the medicaldevice 20) and a central passageway 36 c, 38 c extending through therespective tube 36, 38. Each tube 36, 38 has a centerline 36 d, 38 dwhich extends from the proximal inlet 36 a, 38 a to the distal outlet 36b, 38 b. The tubes 26, 28 are curved along the length of each tube 26,28 and the centerlines 36 d, 38 d are accordingly curved. Each tube 26,28 has a diameter which is preferably 15 mm, however, each tube 26, 28may be bigger or smaller, and/or not of equal diameter with respect toeach other. Each tube 26, 28 is formed of a relatively stiff butcompliant plastics material and is preferably formed by extrusion. Thetubes 26, 28 are situated side-by-side and thus the centerlines 36 d, 38d of the tubes 26, 28 are parallel to each other. The inlets 36 a, 38 agenerally align with each other, and the outlets 36 b, 38 b generallyalign with each other. Proximate to the distal outlets 36 b, 38 b of thetubes 26, 28, the inner portions of the walls 36, 38 merge together atthe dome 30.

The dome 30 is formed of a plastics material like that of the tubes 26,28. The dome 30 has a ramped surface 40 proximate to the intubating tube28 which acts as a ramp for the insertion of the endotracheal tube 24into the throat of the patient 22. The perimeter 31 of the dome 30distal from the distal ends of the tubes 26, 28 generally forms anellipse.

The centerlines 36 d, 38 d of the tubes 26, 28 generally fall along themajor axis 31 f of the ellipse and are offset from each other, with onecenterline 36 d proximate to one focus 31 a of the ellipse and the othercenterline 38 d proximate to the other focus 31 b of the ellipse. Asschematically shown in FIG. 8, the distal open outlet 36 b of theventilating tube 26 generally aligns with focus 31 a and forms aventilating passageway. The distal open outlet 38 c of the intubatingtube 28 generally aligns with focus 31 b. The ramped surface 40 isbetween distal open outlet 38 c of the intubating tube 28 and the vertex31 d of the ellipse. The inner portions of the walls 36, 38 preferablygenerally align with the center 31 c of the ellipse. The intubating tube28 and the ramped surface 40 form an intubating passageway along theirlengths. While the distal open outlet 38 c of the intubating tube 28 isdescribed and shown as generally aligning with focus 31 b, it is to beunderstood that the ramped surface 40 can be positioned to generallyalign with this focus 31 b.

The inflatable cuff 32, if provided, surrounds the perimeter 31 of thedome 30. A central opening 42 is formed by the cuff 32. The inner edgeof the cuff 32 is bonded or otherwise suitably secured, such as byultrasonic welding, to the perimeter 31 of the dome 30. Thus the inneredge of the cuff 32 is generally elliptical. The cuff 32 is preferablyformed of a thin, flexible plastics material so that the cuff 32 can bedeflated to a low profile for insertion into the patient 22 and can beinflated to seal with the surrounding tissue when the medical device 20is correctly positioned in the throat of the patient 22 as describedherein.

The medical device 20 includes an inflation line 44 which is formed by asmall diameter flexible plastic tube. As shown, the inflation line 44 isprovided proximate to the ventilating tube 26 at a position farthestfrom the intubating tube 28. This position is only illustrative and theinflation line 44 can be provided at other locations. The distal end ofthe inflatable cuff 32 is scaled with the outside of the inflation line44 so that it opens into the interior of the inflatable cuff 32. Theproximal end of the inflation line 44 is attached to a combinedinflation indicator balloon and connector 46 which are known in the art.The inflation line 44 can be attached to one of the tubes 26, 28 alongits length, if desired. Alternatively, an extruded small-bore lumen (notshown) can be provided within the wall 36, 28 of one of the tubes 26, 28to provide the inflation line 44.

A cap 48 is provided at the proximal end of the intubating tube 28 forsealing the proximal outlet 38 a of the intubating tube 28 when it isnot in use. Preferably, the cap 48 is formed of rubber. The cap 48 canhave a flip-top, or can be removed from the intubating tube 28, to allowaccess to the intubating passageway when needed. Other means for sealingthe end of the intubating tube 28, while selectively allowing access tothe intubating passageway therein, are within the scope of the presentinvention.

The camera lumen 58 has a distal end which is preferably provided at thevertex 31 e of the ellipse between the ventilating tube 26 and the cuff32. The ventilating tube 26 and the cuff 32 are sealed to the cameralumen 58 by suitable means. Instead of a separate lumen attached to theventilating tube 26 and the cuff 32, an extruded small-bore lumen can beprovided within the wall of the ventilating tube 26, with the window 60sealed to the end thereof. The camera 66 is preferably provided at thevertex 31 e of the ellipse between the ventilating tube 26 and the cuff32 as this provides the best angle for viewing the tissues of thepatient 22 when the medical device 20 is being inserted. It is to beunderstood that the camera 66 can be placed in other positions.

The transmission lumen 68 seats against the intubating tube 28 and thedistal end of the transmission lumen 68 is attached to the cuff 32 or isattached near the distal outlet 38 b of the ventilating tube 26 near thecuff 32, such that the end of the transmission lumen 68 is positionedproximate to the ramped surface 40. When the medical device 20 is seatedin the throat of the patient 22, the distal end of the transmissionlumen 68 is positioned closest to the esophagus 80 which enables breathand heartbeat sounds to be easily transmitted through the perforations70 and along the length of the transmission lumen 68 to the medicalprofessional monitoring the patient 22.

In use, the medical professional inserts the medical device 20 throughthe mouth and into the throat of the patient 22. The intubating tube 28is closed by the cap 48 at its proximal outlet 38 a and is not used. Theventilating tube 26 remains open to allow the patient 22 to breathe onhis/her own through the ventilating tube 26 through the open proximalinlet 36 a of the ventilating tube 26. The ventilating tube 26 can alsobe connected to the ventilator 23 to provide assisted breathing to thepatient 22. The cuff 32 and the intubating tube 28 slide against thehard palate and then against the soft palate and into the pharynx of thepatient 22. The medical device 20 will flex to assume a curved shape toconform to the throat of the patient 22. The medical professional usesthe camera 66 to properly guide the medical device 20 into the pharynx.Because the camera 66 provides constant visualization of the tissuesduring insertion of the medical device 20 into the patient, the medicalprofessional can be assured that the medical device 20 is being properlyinserted and positioned in the throat of the patient 22 with limitedtrauma to the patient 22. The medical professional can see the vocalfolds via the camera 66 to ensure proper positioning of the medicaldevice 20 in the patient's throat. Once positioned in the pharynx, oneend 73 of the cuff 32 seats against the epiglottis 74 pushing it towardthe tongue 76 of the patient 22 and the opposite end 78 of the cuff 32seats in the esophagus 80. The cuff 32 is then inflated. As a result,the esophagus 80 is blocked by the cuff 32 and the epiglottis 74 ismoved out of the way of the ventilating and intubating passageways 36 c,38 c. The distal outlets 36 b, 38 b of the ventilating and intubatingpassageways 36 c. 38 c are open to the glottis of the patient 22. Duringthis entire procedure of insertion, the camera 66 provides constantvisualization of the tissues during insertion of the medical device 20into the patient 22. The patient 22 can breathe by airflow through theopen ventilating tube 26. Since the camera 66 is constantly operatingduring insertion and through the entire medical procedure, the medicalprofessional can constantly visually confirm that the patient 22 isbreathing. The constant visualization of the laryngeal inlet and thevocal folds of the patient 22 can make earlier diagnoses of issues, forexample, but not limited to, secretions, tumors, paralyzed vocal folds,apnea, bleeding, and abnormal anatomy, as well as other potentiallyharmful effects to the patient 22.

If the medical professional needs to insert an endotracheal tube 24 intothe patient 22, the cap 48 on the intubating tube 28 is removed/openedand the endotracheal tube 24 is inserted through the proximal outlet 38a of the intubating tube 28 and through the passageway 36 c of theintubating tube 28. The endotracheal tube 24 will contact the rampedsurface 40 which properly directs the endotracheal tube 24 into thepharynx. Once the endotracheal tube 24 exits the intubating tube 28 atits distal outlet 38 b, the medical professional can see the positioningof the endotracheal tube 24 via the camera 66. The medical professionalcan thus guide the endotracheal tube 24 through the vocal folds and intothe trachea, and inflate the cuff of the endotracheal tube 24, under theconstant visualization provided by the camera 66. At times, the medicaldevice 20 may be advanced, pulled back, or turned from side to side, tomaintain the proper trajectory through the vocal folds. This is easilyaccomplished since there is constant visualization of the tissues viathe camera 66. In addition, known moveable stylets (not shown) may beused. The ventilator 23 is then disconnected from the ventilating tube26 and the ventilating tube 26 is capped, or the ventilator 23 remainsconnected, but turned off.

As a result of the structure of the medical device 20, the intubatingtube 28 is located furthest away from the epiglottis 74 when the medicaldevice 20 is positioned within the patient 22. This minimizes theability of the epiglottis 74 to block the insertion of the endotrachealtube 24 into the trachea in the event that the epiglottis 74 is notseated between the cuff 32 and the tongue 76.

Attention is now invited to the second embodiment of the medical device120 shown in FIGS. 9 and 10 which shows the specifics of the dual-tubedesign.

Each tube 126, 128 is formed from a cylindrical wall 136, 138 having aproximal open inlet 136 a, 138 a (at the ends closest to the medicalprofessional), an opposite open distal outlet 136 b, 138 b (at the endsfurthest away from the medical professional during use of the medicaldevice 120) and a central passageway 136 c, 138 c extending through therespective tube 126, 128. Tube 128 is shown in full line in FIG. 9 toillustrate the construction of the tube 128 (of course, in practice,tube 126 may be opaque such that tube 128 would not be visible along itslength). The outlets 136 b, 138 b generally align with each other. Eachtube 126, 128 has a centerline 136 d, 138 d which extends from theproximal inlet 136 a, 138 a to the distal outlet 1366, 138 b. The tubes126, 128 are curved along the lengths thereof and the centerlines 136 d,138 d are accordingly curved. Each tube 126, 128 is formed of arelatively stiff but compliant plastics material and is preferablyformed by extrusion. Tube 126 forms the ventilating tube, however, tube128 is also used in the ventilating process as described herein. Tube128 forms the intubating tube.

The intubating tube 128 is positioned within the ventilating tube 126. Aportion of the wall 136 of the ventilating tube 126 is preferablyconnected to the intubating tube 128, as shown in FIG. 9, along ajunction 150 to affix the tubes 126, 128 together and to prevent theintubating tube 128 from moving around within the ventilating tube 126.The centerlines of the tubes 126, 128 are parallel to each other. Theventilating tube 216 has a diameter which is preferably 20 mm, and theintubating tube 128 has a diameter which is preferably 10 mm.

The intubating tube 128 has an elongated slit 152 along its lengthopposite to the junction 150 to allow for gas communication between thepassageway 136 c of the ventilating tube 126 and the passageway 138 c ofthe intubating tube 128. The slit 152 can extend the entire length ofthe intubating tube 128 as shown, or can extend along a portion of thelength of the intubating tube 128.

The ventilating tube 126 has a ventilating port 154 in its wall 136proximate to, but spaced from, the proximal open inlet 136 a thereof.The ventilating port 154 is preferably proximate to the slit 152 in theintubating tube 128. A connector tube 156 is formed around theventilating port 154. The connector tube 156 may be integrally formedwith the ventilating tube 126, or may be a separate component which issealed to the ventilating tube 126 by known means.

The dome 130 is formed of a plastics material like that of the tubes126, 128. The dome 130 is formed at the distal outlet 136 b of theventilating tube 126. The dome 130 has a ramped surface 140 whichconnects to the intubating tube 128 to act as a ramp for the insertionof the endotracheal tube 24 into the throat of the patient 22 asdescribed herein. The perimeter 131 of the dome 30 distal from thedistal ends of the tubes 126, 128 generally forms an ellipse.

The inflatable cuff 132 surrounds the perimeter 131 of the dome 130. Acentral opening 142 is formed by the cuff 132. The inner edge of thecuff 132 is bonded or otherwise suitably secured, such as by ultrasonicwelding, to the perimeter 131 of the dome 130. Thus the inner edge ofthe cuff 32 is generally elliptical. The cuff 132 is preferably formedof a thin, flexible plastics material so that the cuff 132 can bedeflated to a low profile for insertion into the patient's throat andcan be inflated once properly positioned to seal with the surroundingtissue when the medical device 120 is correctly positioned in the throatof the patient 22 as described herein.

The centerlines 136 d, 138 d of the tubes 126, 128 generally fall alongthe major axis 31 f of the ellipse and are offset from each other. Asschematically shown in FIG. 10, the distal open outlet 136 b of theventilating tube 126 generally aligns with both foci 31 a, 31 b as thisventilating tube 126 is large. The distal open outlet 138 c of theintubating tube 128 generally aligns with one focus 31 b. The rampedsurface 140 is between distal open outlet 136 c of the ventilating tube128 and the vertex 31 d of the ellipse. The intubating tube 128 and theramped surface 140 form an intubating passageway.

The medical device 120 includes an inflation line like that of the firstembodiment (not shown in FIG. 8) and therefore, the specifics are notrepeated herein. Like elements are denoted by like reference numeralswith the elements of the second embodiment being denoted with referencenumerals in the one-hundreds.

A cap 148 attaches to the proximal inlet 136 a of the ventilating tube126 to prevent access to the open proximal outlet 138 a of theintubating tube 128 when the endotracheal tube 24 is not being used.Preferably, the cap 148 is formed of rubber. The cap 148 can have aflip-top as shown to allow access to the intubating passageway 138 c, orcan be removed from the ventilating tube 126 to allow access to theintubating passageway 138 c. Other means for sealing the end of theventilating tube 126, while selectively allowing access to theintubating passageway 138 c, are within the scope of the presentinvention.

The transmission lumen 68 seats against the ventilating tube 126 and thedistal end of the transmission lumen 68 is either attached to the cuff132 or is attached near the distal outlet 138 b of the ventilating tube126 near the cuff 132. When the medical device 120 is seated in thethroat of the patient 22, the distal end of the transmission lumen 68 ispositioned closest to the esophagus 80 which enables breath andheartbeat sounds to be easily transmitted through the perforations 170and along the length of the transmission lumen 68 to the medicalprofessional monitoring the patient 22.

The distal end of the camera lumen 58 is preferably provided at thevertex 31 e of the ellipse between the ventilating tube 126 and the cuff132 which are sealed thereto. Alternatively, an extruded small-borelumen can be provided within the wall of the ventilating tube 126, withthe window 60 sealed to the end thereof. The camera 66 is preferablyprovided at the vertex 31 e of the ellipse between the ventilating tube126 and the cuff 132 as this provides the best angle for viewing thetissues of the patient 22 when the medical device 120 is being inserted.It is to be understood that the camera 66 and camera lumen 58 can beplaced in other positions.

In use, the medical professional inserts the medical device 120 throughthe mouth and into the throat of the patient 22. The open ventilatingtube 126 allows the patient 22 to breathe on his/her own through theconnector 156 attached to the ventilating tube 126. The ventilating tube126 can also be connected to the ventilator 23 to provide assistedbreathing to the patient 22. The cuff 132 and the ventilating tube 126slide against the hard palate and then against the soft palate and intothe pharynx of the patient 22. The medical device 120 will flex toassume a curved shape to conform to the throat of the patient 22. Themedical professional uses the camera 66 to properly guide the medicaldevice 120 into the pharynx. Because the camera 66 provides constantvisualization of the tissues during insertion and the entire time thatthe medical device 120 is in the patient 22, the medical professionalcan be assured that the medical device 120 is being properly insertedand maintained. The medical professional can see the vocal folds via thecamera 66 to ensure proper positioning of the medical device 120 in thepatient's throat. Since the camera 66 is constantly operating, themedical professional can constantly visually confirm movement of thevocal folds to be assured that the patient 22 is breathing. Oncepositioned in the pharynx, the proximal end of the cuff 132 seatsagainst the epiglottis 74 pushing it toward the tongue 76 of the patient22 and the distal end of the cuff 132 seats in the esophagus 80. Thecuff 132 is then inflated. As a result, the esophagus 80 is blocked bythe cuff 132 and the epiglottis 74 is moved out of the way of theventilating and intubating passageways 136 c, 138 c. The distal outlets136 b, 138 b of the intubating tube 126 and the ventilating tube 128 areopen to the glottis of the patient 22. During this entire procedure, thecamera 66 provides constant visualization of the tissues duringinsertion of the medical device 120 into the patient 22 and continuesthroughout the entire medical procedure. The constant visualization ofthe laryngeal inlet and the vocal folds of the patient 22 can makeearlier diagnoses of issues, for example, but not limited to,secretions, tumors, paralyzed vocal folds, apnea, bleeding, and abnormalanatomy, as well as other potentially harmful effects to the patient 22.

The patient can breathe by airflow through the connector 56/ventilatingtube 126. Air can also flow through the slit 152 and through theintubating tube 128 to the patient 22.

If the medical professional needs to insert an endotracheal tube 24 intothe patient 22, the cap 148 is removed/opened (opened via removing theplug 148 a on the cap 148 to open the passageway 148 b in the cap 148)to allow access to the proximal outlet 138 a of the intubating tube 128and the endotracheal tube 24 is inserted through the proximal outlet 138a and through the intubating passageway 138 c. The endotracheal tube 24will contact the ramped surface 140 which properly directs theendotracheal tube 24 into the pharynx. Once the endotracheal tube 24exits the intubating tube 28, the medical professional can see thepositioning of the endotracheal tube 24 via the camera 66. The medicalprofessional can thus guide the endotracheal tube 24 through the vocalfolds and into the trachea, and then inflate the cuff of theendotracheal tube 24, under the constant visualization provided by thecamera 66. At times, the medical device 120 may be advanced, pulledback, or turned from side to side, to maintain the proper trajectorythrough the vocal folds. In addition, known moveable stylets (not shown)may be used. The ventilator 23 is then disconnected from the ventilatingtube 26 and the connector 156 may be capped (although it can be leftopen since the endotracheal tube 24 is in place), or the ventilator 23can remain connected, but turned off.

In this embodiment of the medical device 120, the ventilating port 154and connector tube 156 can be moved from the tube 126 to a modified cap148′ as shown in FIG. 9A (like that=of FIG. 9, tube 128 is shown in fullline in FIG. 9A to illustrate the construction of the tube 128 (ofcourse, in practice, tube 126 may be opaque such that tube 128 would notbe visible along its length)). This modified cap 148′ allows forventilation (via ventilation port 56/connector tube 154), intubation(intubation is achieved by removing the plug 148 a on the cap 148′ toopen the passageway 148 b in the cap 148′), and connection to the tube128. The skirt 148 c of the cap 148 is longer than the skirt of the cap148 to accommodate the ventilation port 156, while still allowing thecap 148′ to be connected to the tube 128.

The intubating tube 128 is located furthest away from the epiglottis 74when the medical device 120 is inserted. This minimizes the ability ofthe epiglottis 74 to block the insertion of the endotracheal tube 24into the trachea of the patient 22 in the event that the epiglottis 74is not seated between the cuff 132 and the tongue 76.

The dual tubes 26/126, 281128 thus provide the ability for a patient 22to breathe on his/her own, to breathe under ventilation via theventilator 23, or to be intubated using the endotracheal tube 24. Theendotracheal tube 24 can be removed from the intubating tube 28, 128 andthe intubating tube 28, 128 capped, and the patient 22 can return tobreathing on his/her own or under ventilation through the ventilatingtube 26, 126 without removal of the medical device 20, 120 from thepatient 22. If the patient 22 becomes distressed or if circumstancesdictate, the endotracheal tube 24 can be reinserted into the intubatingtube 28, 128. This provides great flexibility for the medicalprofessional to keep the patient's airway open, to constantly visuallyverify that the patient's airway is open during the entire medicalprocedure, and to constantly verify by hearing that the patient's airwayis open during the entire procedure.

The transmission lumen 68 is positioned proximate to the esophagus 80which is the location closest to the lungs and heart of the patient 22.This enables breath and heart sounds to be easily transmitted along thetransmission lumen 68.

The medical device 20, 120 is intended to be in the patient 22 duringthe entire medical procedure. The video information from the camera 66and the information from the transmission lumen 68 are transmitted to amicroprocessor 82, FIG. 11, via appropriate means, such as wires,wireless, Bluetooth, etc., which in turn can transmit the information toanother computer, mobile devices, a mobile station and the like, viaappropriate means, such as wires, wireless, Bluetooth, etc., and thenthis information can be accessed by appropriate personnel. Thismicroprocessor 82 can be on-site where the procedure is being performedor can be remote from the procedure site. For example, the informationcan be supplied to the nurses' station and the nurse on duty will beable to instantly know if the patient 22 is breathing by the visualconfirmation that the vocal folds are opening and closing and by hearingbreath and heart sounds. The medical professional will be able tointerpret the depth of anesthesia by looking at the rhythmic movement ofthe vocal folds as well as other diagnoses previously mentioned. Othermedical personnel can be hundreds of miles away and still be able tomonitor, advise, confirm, and diagnose without the patient 22 being inclose physical proximity to that medical personnel. Since the camera 66is constantly operating, medical personnel can tell at any time if thepatient 22 is properly ventilated/intubated and is breathing.

If desired, the medical device 20, 120 can be removed once theendotracheal tube 24 is properly positioned because the intubatingpassageway 38 c, 138 c is sufficiently large to slide over theendotracheal tube 24 without dislodging the endotracheal tube 24 fromthe patient's throat.

A temperature sensor (not shown) can also be incorporated into themedical device 20, 120 for providing temperature information to theappropriate personnel via the microprocessor 82.

The medical device 20, 120 is disposable. Since the camera 66 is removedfrom the medical device 20, 120 before disposal, an expensive componentof the medical device 20, 120 is reusable. While the lights 62 aredescribed as being provided in the medical device 20, 120, it ispossible for the lights 62 to be built into the camera 66.

FIGS. 12-16 show a first embodiment of an airway assist device 84 andFIGS. 17-20 show a second embodiment of an airway assist device 184,each of which are used in combination with the medical device 20, 120.The airway assist device 84, 184 can be used to manipulate the positionof the patient's epiglottis 74 and tongue 76 to further ensure that theepiglottis 74 and tongue 76 are moved out of the way of the ventilatingand intubating passageways 36 c, 136 c, 38 c, 138 c and to minimize thechance of blockage of the passageways 36 c. 136 c, 38 c, 138 c by theepiglottis 74. These airway assist devices 84, 184 allow firstresponders, for example, paramedics, an easier way to provide patency tothe airway of the patient 22, and to easily advance the medical device20, 120 under constant visualization by the camera 66.

Attention is invited to the airway assist device 84 shown in FIGS.12-16. The airway assist device 84 is formed from an airway holder 86and a tongue positioner 96.

The airway holder 86 is formed of a cylindrical tube which has a centralpassageway 86 c extending from a proximal end 86 a thereof to a distalend 86 b thereof. The central passageway 86 c has a large enoughdiameter to allow the medical device 20, 120 to pass therethrough. Theairway holder 86 is preferably curved in the same shape as the medicaldevices 20, 120.

An elongated mounting extension 88 extends from the airway holder 86.The mounting extension 88 has a dovetail opening 90 extending along thelength thereof. Alternatively, the wall of the airway holder 86 could bethickened and the dovetail opening 90 formed therein. A collar 92 isprovided at the proximal end 86 a of the airway holder 86 and extendsperpendicularly therefrom.

The airway assist device 84 includes a camera lumen 58 for housing acamera 66 and a transmission lumen 68 attached to the outer surface ofthe airway holder 86 at a position which is diametrically opposed to themounting extension 88. The camera lumen 58, the camera 66 and thetransmission lumen 68 are identical to those shown in the medicaldevices 20, 120 and the specifics are therefore not repeated. A lumen 94for housing a temperature sensor is also provided (such a lumen 94 andtemperature can be provided with the medical devices 20, 120). As shown,the lumens 58, 68, 94 are positioned side-by-side and attached to theairway holder 86 by suitable means. The lumens 58, 68, 94 can beintegrally formed with the airway holder 86.

The tongue positioner 96 is slidably received in the mounting extension88. The tongue positioner 96 has an elongated body 98 which is curvedand has a distal end 100 which has a radius which is substantiallygreater than the radius at which the body 98 is curved. The edge 102 ofthe distal end 100 is preferably arcuate. A handle 104 is provided atthe proximal end of the body 98 which enables a medical professional tograsp the tongue positioner 96. The tongue positioner 96 is preferablyformed of a rigid plastic. The distal end 100 may be covered with a softmaterial, such as silicone. A dovetail protrusion 1 06 extends outwardlyfrom the body 98 and seats within the dovetail slot 90 in the mountingextension 88.

A series of spaced apart ratchet teeth 108 extend outwardly from thebody 98 proximate to the handle 104. The teeth 108 are capable ofengaging with the collar 92 to hold the position of the tonguepositioner 96 proximally and distally relative to the airway holder 86.

In use, the medical professional inserts the airway assist device 84into the mouth of the patient 22. The airway holder 86/lumens 58, 68, 9428 slide against the hard palate and then against the soft palate andpartially into the pharynx of the patient 22 until the distal end 1 00of the airway assist device 84 enters into the vallecula 11 0 and theedge 102 engages the tissues of the patient 22. The tongue positioner 96may slide along the patient's tongue 76. The camera 66 on the airwayassist device 84 allows the medical professional to see the tissues anddetermine the proper positioning of the airway assist device 84. Onceproperly positioned in the vallecula 110, the medical professional pullson the handle 104 to move the tongue positioner 96 proximally relativeto the medical device tube 86. The distal end 100 engages the patient'stongue 76 and pulls the tongue 76 proximally toward the outside of themouth of the patient 22. As a result, the epiglottis 74 is also pulledproximally to further open the airway of the patient 22. The teeth 1 08ratchet on the collar 92 of the airway holder 86 and prevent the tonguepositioner 96 from moving distally relative to the airway holder 86.During this procedure, the patient 22 can breathe through the centralpassageway 86 c of the airway holder 86.

When the epiglottis 74 is pulled proximally, the medical professionalinserts the medical device 20, 120 into the central passageway 86 c ofthe airway assist device 84 and properly positions the medical device20, 120 in the patient's throat as described herein.

After insertion of the medical device 20, 120, the medical professionalreleases the 14 patient's tongue 76 by pulling the tongue positioner 96away from the airway holder 86 to disengage the teeth 108 from thecollar 92. The rigid plastic of the tongue positioner 96 has enoughflexibility to allow the elastic deformation of the tongue positioner96. Once the teeth 108 are disengaged from the collar 92, the medicalprofessional pushes the tongue positioner 96 distally relative to theairway holder 86 to cause the tongue 76 of the patient to moverearwardly into the patient's mouth. Thereafter, the airway assistdevice 84 can be removed from the patient's mouth by sliding it over themedical device 20, 120.

Attention is invited to the airway assist device 184 shown in FIGS.17-20. With this embodiment, the ventilating tube 26, 126 has a collar192 at its proximal end which extends=perpendicularly from theventilating tube 26, 126.

The airway assist device 184 includes a tongue positioner 196 having anelongated body 198 which is curved and has a distal end 200 which has aradius which is substantially greater than the radius at which the body198 is curved. The edge 202 of the distal end 200 is preferably arcuate.A handle 204 is provided at the proximal end of the body 198 whichenables a medical professional to grasp the tongue positioner 196. Thetongue positioner 196 is preferably formed of a rigid plastic. Thedistal end 200 may be covered with a soft material, such as silicone.

The airway holder 186 includes a pair of tabs 212 and a pair of arms216.

The tabs 212 extend upwardly from the distal end 200 proximate to, butspaced from, the edge 202. Each tab 212 is curved and aligned with eachother such that the ends of the tabs 212 face each other. As a result, aspace 214 is formed between each of the tabs 212 and the distal end 200.This space 214 has a dimension which is approximately equal to theinflatable cuff 32, 132 in the deflated condition. The tabs 212 arespaced apart from each other a distance which is generally equal to thewidth of the inflatable cuff 32, 132.

The arms 216 extend upwardly from the body 198. Each arm 216 isgenerally L-shaped, with a first section 216 a extending perpendicularlyfrom the body 198 and second sections 216 b extending perpendicularlyfrom the first section 216 a. The ends of the second sections 216 b arespaced apart from each other to form a slot 218. The slot 218 has awidth which is slightly less than the diameter of the medical device 20,120. The arms 216 and the body 198 form a medical device receivingpassageway 186. A tooth 208 extends upwardly from the proximal end ofthe body 198 between the arms 216. The tooth 208 is capable of engagingwith the collar 192.

In use, the medical professional first inserts the medical device 20,120 into the airway assist device 184 by inserting the medical device20, 120 through the slot 218 and into the central passageway 186 of theairway assist device 184. The arms 216 can elastically flex outwardly asnecessary to allow the medical device 20, 120 to pass through the slot218. The cuff 32, 132 seats underneath the tabs 212 such that the cuff32, 132 is sandwiched between the tabs 212 and the distal end 200.

The medical professional then inserts the combined medical device 20,120/airway assist device 184 into the mouth of the patient 22. Theairway assist device 184 is sandwiched between the medical device 20,120 and the tongue 76 of the patient 22. The medical device 20, 120slides against the hard palate and then against the soft palate andpartially into the pharynx of the patient 22 until the distal end 100 ofthe airway assist device 84 enters into the vallecula 11 0 and thearcuate edge 202 engages the tissues of the patient 22. The camera 66 onthe medical device 20, 120 provides visual means to the medicalprofessional to properly insert the distal end 200 into the vallecula110. The tongue positioner 196 may slide along the patient's tongue 76.Once the distal end 200 is positioned in the vallecula 110, the medicalprofessional pulls on the handle 204 to move the tongue positioner 196proximally relative to the medical device 20, 120. The distal end 200engages the tongue 76 and pulls the tongue 76 proximally toward theoutside of the mouth of the patient 22. As a result, the epiglottis 74is also pulled proximally. During this procedure, the patient 22 canbreathe through the medical device 20, 120 as described herein.

When the epiglottis 74 is pulled proximally, the medical professionalthen pulls the medical device 20, 120 proximally to release the cuff 32,132 from the tabs 212. The freed medical device 20, 120 then can befinally inserted with the distal end of the medical device 20, 120 inthe upper esophagus 80 of the patient 22 as discussed above.

After insertion of the medical device 20, 120, the medical professionalreleases the patient's tongue 76 by pushing the tongue positioner 196distally into the patient's mouth to cause the tongue 76 of the patientto move rearwardly. Thereafter, the airway assist device 184 can beremoved from the patient's mouth by sliding it over the medical device20, 120.

While the cuff 32, 132 has been described as inflatable, the cuff 32,132 can be formed of a soft material, such as silicone, which willreadily seal with the tissues in the glottis when the medical device 20,120 is seated therein.

FIGS. 21-25E show a medical device 220 which is inserted into the throatof a patient 22 to determine the status of the internal membranes of thepatient 22 and to provide a means for intubating the patient 22 with anendotracheal tube 24. The medical device 220 includes an esophageal tube226 and an intubating tube 228 which are connected together. Theesophageal tube 226 is used to monitor breath sounds of the patient 22,and the intubating tube 228 is used for intubation of the patient 22using the endotracheal tube 24 as described herein.

The esophageal tube 226 is formed from an elongated tube wall which asshown in FIG. 23 has first and second portions 230, 232 which arearcuate and which are connected to each other by curved end portions234, 236. The first and second portions 230, 232 are preferably separatefrom each other by a distance of mm and the end portions 234, 236 arepreferably separated from each other by a distance of 5 mm, however, theesophageal tube 226 may be bigger or smaller. The proximal end of theesophageal tube 226 is open and provides a proximal inlet opening 238. Agenerally conical end portion 240, see FIG. 24, having an aperture 242therethrough is provided at the distal end of the tube wall. A centralpassageway 244 extends through the tube wall and through the conical endportion 240. The aperture 242 is in communication with the centralpassageway 244. The esophageal tube 226 is curved along its length. Theesophageal tube 226 is formed of a relatively stiff but compliantplastics material and is preferably formed by extrusion.

A transmission lumen 68 like that of the first and second embodiments ofthe medical device 20, 120 is provided and the specifics are notrepeated herein. The transmission lumen 68 seats within the centralpassageway 244 of the esophageal tube 226 and extends from the aperture242. The transmission lumen 68 may seat freely in the esophageal tube226, may be attached to the esophageal tube 226 by a friction fit withthe aperture 242, or the transmission lumen 68 can be otherwise affixedto the esophageal tube 226.

The intubating tube 228 is formed from a small diameter cylindrical wall246 having a proximal open inlet (at the end closest to the medicalprofessional), an opposite distal open outlet (at the end furthest awayfrom the medical professional during use of the medical device 220), acentral passageway 248 extending therethrough, and a slot 250 which isin fluid communication with the central passageway 248 and extends fromthe proximal end (at inlet) to the distal end (at outlet) of theintubating tube 228. The intubating tube 228 is curved along its length.The intubating tube 228 has a diameter which is preferably 4 mm,however, the intubating tube 228 may be bigger or smaller. Theintubating tube 228 is formed of a relatively stiff but compliantplastics material and is preferably formed by extrusion.

A camera lumen 58/window 60 and camera 66 like that of the first andsecond embodiments of the medical device 20, 120 are provided and thespecifics are not repeated herein.

The intubating tube 228 is affixed, such as by ultrasonic welding, tothe esophageal tube 226 along the second wall portion 232. The cameralumen 58 is affixed, such as by ultrasonic welding, to the esophagealtube 226 along the second wall portion 232 and is proximate to theintubating tube 228. The camera 66 and LED lights 62 (or other source oflighting, including a camera with its own built-in lighting) can beincorporated into a single device which is insertable and removeablefrom the camera lumen 58. The camera 66 is situated to provide the bestangle for viewing the tissues of the patient 22 when the medical device220 is being inserted into the throat of a patient 22. As a result, theintubating tube 228 and the camera lumen 58 are situated side-by-side.The inlets of the esophageal tube 226, the intubating tube 228 and thecamera lumen 58 generally align with each other. The outlets do notalign with each other; instead, the outlets of the intubating tube 228and the camera lumen 58 are spaced proximally a predetermined distancefrom the outlet of the esophageal tube 226. The slot 250 in theintubating tube 228 is opposite to the point of weldment of theintubating tube 228 to the esophageal tube 226 to provide a means forinsertion of the endotracheal tube 24 into the patient 22 as describedherein.

In use, the medical professional inserts the medical device 220 throughthe mouth and into the throat of the patient 22. The esophageal tube 226slides against the hard palate and then against the soft palate and intothe pharynx of the patient 22. The medical device 220 will flex toassume a curved shape to conform to the throat of the patient 22. Themedical device 220 does not block the airway of the patient 22 so thepatient 22 can breathe on his/her own. The generally conical end wall240 of the esophageal tube 226 enters into the upper end of esophagus 80such that the transmission lumen 68 is positioned within the esophagus80 and is located closest to the lungs of the patient 22. The distaloutlet of the intubating tube 228 is open to the glottis of the patient22. During this entire procedure of insertion, the camera 66 providesconstant visualization of the tissues during insertion of the medicaldevice 220 into the patient 22. Because the camera 66 provides constantvisualization of the tissues during insertion of the medical device 220into the patient, the medical professional can be assured that themedical device 220 is being properly inserted and positioned in thethroat of the patient 22 with limited trauma to the patient 22. Sincethe camera lumen 58 terminates proximally of the esophageal tube 226 anddoes not enter into the esophagus 80, the medical professional can seethe vocal folds 82 via the camera 66. Since the camera 66 is constantlyoperating during insertion and through the entire medical procedure, themedical professional can constantly visually confirm that the patient 22is breathing by the rhythmic opening and closing of the vocal folds 82.The constant visualization of the laryngeal inlet and the vocal folds 82of the patient 22 can make earlier diagnoses of issues, for example, butnot limited to, secretions, tumors, paralyzed vocal folds, apnea,bleeding, and abnormal anatomy, as well as other potentially harmfuleffects to the patient 22.

The medical device 220 is used to insert the endotracheal tube 24.First, a stylet 252, which is known in the art, is inserted into theintubating tube 228 and the distal end thereof preferably extends pastthe distal end of the intubating tube. The stylet 252 rides along theportion of the wall 246 of the intubating tube 228 which is proximate tothe point of weldment to the esophageal tube 226, and, as such, will notbe prone to falling through the slot 250. Thereafter, the distal end ofthe endotracheal tube 24 is threaded over the proximal end of the stylet252 (the portion of the stylet 252 which extends from the proximal endof the intubating tube 228). As the endotracheal tube 24 is pushed alongthe stylet 252, the stylet 252 is pulled upwardly to release it from theintubating tube 228 by the stylet 252 moving through the slot 250. As aresult, the endotracheal tube 24 is guided along the proper path by thestylet 252 and the intubating tube 228. Once the stylet 252 is completedreleased from the intubating tube 228, the endotracheal tube 24 can befurther inserted through the vocal folds 82 of the patient 22 under thevisualization provided by the camera 66. The medical professional canthus guide the endotracheal tube 24 through the vocal folds 82 and intothe trachea, and inflate the cuff of the endotracheal tube 24, under theconstant visualization provided by the camera 66. At times, the medicaldevice 220 may be advanced, pulled back, or turned from side to side, tomaintain the proper trajectory of the endotracheal tube 24 through thevocal folds 82. This is easily accomplished since there is constantvisualization of the tissues via the camera 66.

When the medical device 220 is seated in the throat of the patient 22,the distal end of the transmission lumen 68 is positioned within theesophagus 80 which enables breath and heartbeat sounds to be easilytransmitted through the transmission lumen 68 to the medicalprofessional monitoring the patient 22 as described herein.

As a result of the structure of the medical device 220, the intubatingtube 228 is located away from the epiglottis 74 of the patient 22 whenthe medical device 220 is positioned within the patient 22. Thisminimizes the ability of the epiglottis 74 to block the insertion of theendotracheal tube 24.

Because of the structure of the medical device 220, the patient 22 doesnot have to be laying on his/her back to effect intubation. The patient22 can be sitting in a chair, or lying face down.

Like that of the medical devices 20, 120, the video information from thecamera 66 and the information from the transmission lumen 68 aretransmitted to a microprocessor 82 via appropriate means, such as wires,wireless, Bluetooth, etc., which in turn can transmit the information toanother computer, mobile devices, a mobile station and the like, viaappropriate means, such as wires, wireless, Bluetooth, etc., and thenthis information can be accessed by appropriate personnel. Thismicroprocessor 82 can be on-site where the procedure is being performedor can be remote from the procedure site. For example, the informationcan be supplied to the nurses' station and the nurse on duty will beable to instantly know if the patient 22 is breathing by the visualconfirmation that the vocal folds are opening and closing and by hearingbreath and heart sounds. The medical professional will be able tointerpret the depth of anesthesia by looking at the rhythmic movement ofthe vocal folds as well as other diagnoses previously mentioned. Othermedical personnel can be hundreds of miles away and still be able tomonitor, advise, confirm, and diagnose without the patient 22 being inclose physical proximity to that medical personnel. Since the camera 66is constantly operating, medical personnel can tell at any time if thepatient 22 is properly ventilated/intubated and is breathing.

FIGS. 26-318 show an alternate medical device 320 which is inserted intothe throat of a patient 22 to determine the status of the internalmembranes of the patient 22 and to provide a means for intubating thepatient 22 with an endotracheal tube 24. The medical device 320 includesan intubating tube 326 and a sleeve 328 which are connected together.The sleeve 328 is rotatable relative to the intubating tube 326.

The intubating tube 328 is formed by an elongated cylindrical body 330which has a generally conical tip 332 at its distal end. The intubatingtube 228 is made of a flexible plastic material. The body 330 has anelongated recess 334 therein which generally extends from the proximalend of the body 330 to the distal end of the body 330. The recess 334 iscurved along its length such that in cross-section it is generallyarcuate as shown in FIG. 28. As a result, a proximal curved ramp surface336 is formed by the recess 334 and extends from the outer surface ofthe body 330 proximate to the distal end thereof distally to the apex338 of the recess 334, and a distal curved ramp surface 340 is formed bythe recess 334 and extends from the outer surface of the body 330proximate to the distal end thereof proximally to the apex 338 of therecess 334. An enlarged cylindrical handle 342 is provided at the distalend of the body 330. The tip 332 has a weight provided therein to makethe tip 332 heavier than the remainder of the medical device 320. Acamera lumen 58/window 60 and separate camera 66 like that of theprevious embodiments of the devices 20, 120, 220 are provided and thespecifics are not repeated herein. The camera lumen 58 is preferablypositioned beside the recess 334 and the distal end of the camera lumen58 is proximate to the distal end of the recess 334. The camera lumen 58is suitably attached to the intubating tube 326 by suitable means, suchas ultrasonic welding. Alternatively, the camera lumen 58 can beprovided integral with the intubating tube 326.

The sleeve 328 is formed from generally C-shaped wall 344 which definesa slot 346 between the opposite ends of the C-shaped wall 344. Thesleeve 328 is made of a flexible plastic material. The sleeve 328 has alength which is less than the length of the recess 334, surrounds aportion of the body 330, and is rotatable relative the body 330 to coverand uncover the majority of the recess 334.

In use, the sleeve 328 is rotated relative to the body 330 such that therecess 334 is partially blocked. The proximal and distal ends of therecess 334 are not blocked by the sleeve 328 such that proximal anddistal openings 348, 350 are formed as shown in FIG. 26. The patient 22then swallows the medical device 320, or the medical professionalinserts the medical device 320 through the mouth and into the throat ofthe patient 22. During this insertion, the recess 334 is proximate tothe tongue 76 of the patient 22. The intubating tube 326 slides againstthe hard palate and then against the soft palate and into the pharynx ofthe patient 22. The medical device 320 will flex to assume a curvedshape to conform to the throat of the patient 22. The medical device 320does not block the airway of the patient 22 so the patient 22 canbreathe on his/her own. The generally conical tip 332 of the intubatingtube enters into the upper end of esophagus 80. The proximal opening 348is positioned exterior to the mouth of the patient 22. The distalopening 350 is open to the glottis of the patient 22. During this entireprocedure of insertion, the camera 66 provides constant visualization ofthe tissues of the patient 22. Because the camera 66 provides constantvisualization, the medical professional can be assured that the medicaldevice 320 is being properly inserted and positioned in the throat ofthe patient 22 with limited trauma to the patient 22. Since the cameralumen 58 terminates proximally of the intubating tube 326 and does notenter into the esophagus 80, the medical professional can see the vocalfolds 82 via the camera 66. Since the camera 66 is constantly operatingduring insertion and through the entire medical procedure, the medicalprofessional can constantly visually confirm that the patient 22 isbreathing. The constant visualization of the laryngeal inlet and thevocal folds 82 of the patient 22 can make earlier diagnoses of issues,for example, but not limited to, secretions, tumors, paralyzed vocalfolds, apnea, bleeding, and abnormal anatomy, as well as otherpotentially harmful effects to the patient 22.

The medical device 320 is then used to insert the endotracheal tube 24.The distal end of the endotracheal tube 24 is inserted into the proximalopening 348 and pushed along the length of the recess 334 until thedistal end and cuff of the endotracheal tube 24 exit through the distalopening 350 and passes through the vocal folds of the patient 22. Theramp surface 340 at the distal end of the recess 334 aids in properlypositioning the endotracheal tube 24 relative to the glottis of thepatient 22. The camera 66 is used to determine the positioning of theendotracheal tube 24 and the medical professional can adjust theposition of the medical device 320 using this constant visualizationprovided by the camera 66 to ensure proper entry of the endotrachealtube 24 through the vocal folds 82 and into the trachea of the patient22. At times, the medical device 320 may be advanced, pulled back, orturned from side to side, to maintain the proper trajectory of theendotracheal tube 24 through the vocal folds 82. This is easilyaccomplished since there is constant visualization of the tissues viathe camera 66. Once the endotracheal tube 24 is properly positioned, thesleeve 328 is rotated relative to the intubating tube 326 and theendotracheal tube 24 is released from the intubating tube 326. Themedical device 320 can then be removed from the patient 22 if desired.

A transmission lumen 68 like that of the previous devices 20, 120, 220may be provided and attached to the intubating tube 326. If provided,when the medical device 320 is seated in the throat of the patient 22,the distal end of the transmission lumen 68 is positioned within theesophagus 80 which enables breath and heartbeat sounds to be easilytransmitted along the length of the transmission lumen 68 to the medicalprofessional monitoring the patient 22 as described herein.

As a result of the structure of the medical device 320, the intubatingtube 326 is located away from the epiglottis 74 of the patient 22 whenthe medical device 320 is positioned within the patient 22. Thisminimizes the ability of the epiglottis 74 to block the insertion of theendotracheal tube 24.

Because of the structure of the medical device 320, the patient 22 doesnot have to be laying on his/her back to effect intubation. The patient22 can be sitting in a chair, or lying face down. The medical devices220, 320 provide a new methodology of intubating the patient 22 byplacing the medical device 220, 320 into the esophagus 80 of the patient22 and working upwardly toward the trachea.

Like that of the previous devices 20, 120, 220, the video informationfrom the camera 66 and the information from the transmission lumen 68are transmitted to a microprocessor 82 via appropriate means, such aswires, wireless, Bluetooth, etc., which in turn can transmit theinformation to another computer, mobile devices, a mobile station andthe like, via appropriate means, such as wires, wireless. Bluetooth,etc., and then this information can be accessed by appropriatepersonnel. This microprocessor 82 can be on-site where the procedure isbeing performed or can be remote from the procedure site. For example,the information can be supplied to the nurses' station and the nurse onduty will be able to instantly know if the patient 22 is breathing bythe visual confirmation that the vocal folds are opening and closing andby hearing breath and heart sounds. The medical professional will beable to interpret the depth of anesthesia by looking at the rhythmicmovement of the vocal folds 82 as well as other diagnoses previouslymentioned. Other medical personnel can be hundreds of miles away andstill be able to monitor, advise, confirm, and diagnose without thepatient 22 being in close physical proximity to that medical personnel.Since the camera 66 is constantly operating, medical personnel can tellat any time if the patient 22 is properly ventilated/intubated and isbreathing.

As an alternative, the endotracheal tube 24 can be seated within therecess 334 prior to insertion of the medical device 320 into the patient22. The distal portion of the endotracheal tube 24 is preferably trappedbetween the sleeve 328 and the body 330 when the medical device 320 isfirst inserted to prevent damage to the cuff of the endotracheal tube24.

FIG. 32 shows a medical device 420 which includes an endotracheal tube24 having the camera lumen 58/window 60 affixed thereto. The cameralumen 58/window 60 and separate camera 66 like that of the previousembodiments of the devices 20, 120, 220, 320 are provided and thespecifics are not repeated herein.

As is known in the art, the endotracheal tube 24 includes a cylindricalwall 24 a formed of a relatively stiff but compliant plastics materialand is preferably formed by extrusion which has a central passagewaytherethrough, a cuff 24 b attached proximate to the distal end of thewall 24 a which is inflatable via inflation line 44 which is formed by asmall-diameter flexible plastic tube. The proximal end of the tube 24 ahas a connector 24 c for connecting the endotracheal tube 24 to aventilating machine in a known manner. The prior art endotracheal tube24 is modified in that a mark 426 is provided thereon which ispreferably one inch proximal of the cuff 24 b.

The camera lumen 58 extends along the length of the wall 24 a and thedistal end of the camera lumen 58 is proximate to the mark 426. Thecamera lumen 58 is suitably attached to the wall 24 a by suitable means,such as ultrasonic welding. Alternatively, the camera lumen 58 can beprovided integral with the wall 24 a.

In use, the medical professional inserts the medical device 420 throughthe mouth and into the throat of the patient 22. The endotracheal tube24 then passes through the vocal folds and into the trachea of thepatient 22. The medical device 420 will flex to assume a curved shape toconform to the throat of the patient 22. If desired, the medical device420 can be inserted into the patient 22 using the medical device 20,120. During this entire procedure of insertion, the camera 66 providesconstant visualization of the tissues during insertion of the medicaldevice 420 into the patient 22. Because the camera 66 provides constantvisualization of the tissues during insertion of the medical device 420into the patient, the medical professional can be assured that themedical device 420 is being properly inserted and positioned in thethroat of the patient 22 with limited trauma to the patient 22. Themedical professional can adjust the position of the medical device 420using this constant visualization provided by the camera 66 to ensureproper entry of the endotracheal tube 24 through the vocal folds andinto the trachea of the patient 22. At times, the medical device 420 maybe advanced, pulled back, or turned from side to side, to maintain theproper trajectory of the endotracheal tube 24 through the vocal folds.This is easily accomplished since there is constant visualization of thetissues via the camera 66.

The portion of the endotracheal tube 24 distal to the mark 426 passesthrough the vocal folds, however, the camera lumen 58 does not passthrough the vocal folds. As such, the camera 66 is used to continuouslyvisualize the vocal folds and to view the portion of the endotrachealtube 24 which is distal to the vocal folds (when the vocal folds areopen) to determine if the endotracheal tube 24 has been properlypositioned. Since camera lumen 58 does not pass through the vocal folds,this provides a smaller dimension of material passing through the vocalfolds. Since the camera 66 is constantly operating during insertion andthrough the entire medical procedure, the medical professional canconstantly visually confirm that the patient 22 is breathing. Theconstant visualization of the laryngeal inlet and the vocal folds of thepatient 22 can make earlier diagnoses of issues, for example, but notlimited to, secretions, tumors, paralyzed vocal folds, apnea, bleeding,and abnormal anatomy, as well as other potentially harmful effects tothe patient 22.

A transmission lumen (not shown) like that of the previous devices 20,120, 220, 320 may be provided and attached to the endotracheal tube 24.If provided, when the medical device 420 is seated in the throat of thepatient 22, the distal end of the transmission lumen is positionedproximate to the esophagus which enables breath and heartbeat sounds tobe easily transmitted through the transmission lumen to the medicalprofessional monitoring the patient 22.

FIGS. 33-35 shown a modified medical device 420′ to that shown in FIG.32 which includes a modified endotracheal tube 24′ and a modified cameralumen 58′. The camera lumen 58′ is attached to the wall 24 a by meanswhich allow the camera lumen 58 to slide relative to the wall 24 a. Asshown, a dovetail joint 428, formed of a tongue on one of the cameralumen 58 and the wall 24 a and of a groove on the other of the cameralumen 58 and the wall 24 a, mounts the camera lumen 58 to the wall 24 a.A small cylindrical tube 430 is affixed to the wall 24 a by suitablemeans, such as ultrasonic welding, and is provided between the cuff 24 band the wall 24 a. A passageway 432 is provided by the small cylindricaltube 430. The distal end of the tube 430 is sealed with a window. Thesmall cylindrical tube 430 is positioned at the end of the structureforming the portion of the dovetail joint 428 on the wall 24 b. Thecamera lumen 58′ has a handle 434 attached to its distal end to allowthe medial professional to grasp the camera lumen 58′ to manipulate theposition of the distal end of the camera lumen 58′ as described herein.

In use, the medical professional can grasp the handle 434 to slide thecamera lumen 58, with the camera 60 mounted therein, along the wall 24 avia the inter-engagement of dovetail joint 428 and to slide the distalend of the camera lumen 58/camera 66 through the small cylindrical tube430. This allows the medical professional to continuously view thetissues of the patient on either side of the vocal folds of the patient22.

A transmission lumen 68 is affixed to the endotracheal tube 24′,preferably to the wall 24 a opposite to that where the camera lumen 58′is located. When the medical device 420 is seated in the throat of thepatient 22, the distal end of the transmission lumen 68 is positionedproximate to the esophagus which enables breath and heartbeat sounds tobe easily transmitted through the transmission lumen 68 to the medicalprofessional monitoring the patient 22.

In the embodiments of the medical device 420, 420′, the camera lumen 58,58′/window 60 could instead be mounted within the endotracheal tube 24,24′, with the mark 426 provided on an interior surface of theendotracheal tube 24, 24′.

FIGS. 36-37B show a medical device 520 formed of a dual branchendotracheal tube 524 which incorporates the sealed camera lumen58/window 60 and separate camera 66 which can be inserted therein andremoved therefrom as described herein. The camera lumen 58/window 60 andseparate camera 66 are like that of the previous embodiments of thedevices 20, 120, 220, 320, 420, 420′ and the specifics are not repeatedherein. The dual branch endotracheal tube 524 is used to separate theleft and right bronchus 526, 528 from each other for surgical purposesand can be used as a normal endotracheal tube which is normally seatedin the trachea of the patient 22. In the prior art, separation of theleft and right bronchus 526, 528 from each other is usually accomplishedusing two lumens which tends to be cumbersome.

The endotracheal tube 524 is formed from a main cylindrical wall 530having a proximal end (end closest to the medical professional duringuse) and a distal end (end furthest from the medical professional duringuse), a first branch cylindrical wall 532 extending from the distal endof the main wall 530, and second branch cylindrical 534 wall extendingfrom the distal end of the main wall 530. The first and second branchwalls 532, 534 are smaller in dimension than the main wall 530, but whenthe dimensions of the branch walls 532, 534 are combined, this dimensionis approximately equal to the dimension of the main wall 530. As aresult, the endotracheal tube 524 has a single inlet port at itsproximal end and first and second outlet ports at its distal end. Acentral passageway extends through the main wall 530, and branchpassageways extend through the branch walls 532, 534, each of which arein communication with the central passageway through the main wall 530.The distal end of the first branch wall 532 has a first port 536 whichterminates proximally of the distal end of the second branch wall 534which forms a second port 538. The second port 538 is angled relative tothe first port 536.

The proximal end of the endotracheal tube 524 is closed with a cap 538.The cap 538 has a first aperture 540 therethrough which can be closedwith a plug 542 in a known manner, and a second aperture 544 providedthrough an extension 544 which extends perpendicular to the centerlineof the main wall 530. A ventilator is attached to the extension 544 in aknown manner to provide positive air pressure to the medical device 520.

An inflatable cuff 548 surrounds the main wall 530 at a position whichis spaced from the branch walls 532, 534. An inflation line 550 and itsassociated pilot 552 is attached to this inflatable cuff 548. Aninflatable cuff 554 surrounds the first branch wall 532 at a positionwhich is spaced from the distal port 536. An inflation line 554 and itsassociated pilot 556 is attached to this inflatable cuff 554. Aninflatable cuff 558 (shown in full line in the figures for ease inunderstanding) is positioned interiorly within the first branch wall 532at a position which is spaced from the distal port 536. An inflationline 560 and its associated pilot 562 is attached to this interiorinflatable cuff 558. The camera lumen 58/window 60 extends through theaperture 540 in the cap 538, through the central passageway in the mainwall 530 and into the second branch passageway through the second wall534 and preferably terminates at, or proximate to, the second port 538.The cap 538 and the lumen 58 can form a frictional fit to prevent thecamera lumen 58 from 28 disengaging from the cap 538. The camera 66 isthen is inserted into the camera lumen 58.

The medical professional inserts the medical device 520, with all of thecuffs 548, 554, 558 in the deflated condition, through the mouth andinto the throat of the patient 22. This insertion can be effected usingthe medical device 20, 120 as described above. The camera 66 mounted inthe medical device 520 provides constant visualization of the tissues ofthe patient 22 during this insertion.

The medical device 520 can be placed in the patient 22 in one of thethree positions. In a first position, the medical device 520 can beplaced such that the main wall 530 and the second branch wall 534 are inthe trachea of the patient 22 and past the vocal folds 82, and the firstbranch wall 532 is in the left main stem bronchus 526 of the patient 22,as shown in FIG. 37 A. In a second position, the medical device 520 canbe placed such that the main wall 530 and the second branch wall 534 arein the trachea of the patient 22 and past the vocal folds 82, and thefirst branch wall 532 is in the right main stem bronchus of the patient22 (not shown). In a third position, the medical device 520 can beplaced such that the main wall 530 and both branch walls 532, 534 are inthe trachea of the patient 22, past the vocal folds 82, but not past thecarina 84, as shown in FIG. 37B.

In use, the medical professional inserts the medical device 520 into thepatient 22. If desired, the medical device 520 can be inserted into thepatient 22 using the medical device 20, 120. The camera 66 is used tocontinuously visualize the position of the medical device 520 duringthis insertion. For surgery, the medical device 520 is positioned suchthat the main wall 530 and the second branch wall 534 seat in thetrachea of the patient 22 and the first branch wall 532 seats into oneof the bronchus of the patient 22 (left as shown in the drawings). Sincethe camera 66 is positioned in the trachea of the patient 22, the carina84 of the patient 22 is always within view and the medical professionalwill know that the first branch wall 532 is positioned within thebronchus of the patient 22. Once properly positioned, the external cut's548, 554 are inflated to hold the medical device 520 in place. Cuff 548engages with the trachea of the patient 22, and cuff 554 engages withthe bronchus of the patient 22. The camera 66 provides visualconfirmation that the cuff 554 has been inflated in the bronchus. Whenthe surgeon wants to operate on the lung, the medical professionaldisconnects the ventilator from extension 544 to allow both lungs todeflate. Thereafter, the internal cuff 558 is inflated to block airflowthrough the branch wall to the bronchus in which the first branch wall532 is seated. Thereafter, ventilation is resumed such that the lungwhich will not be operated upon is functioning. Once the medicalprocedure is completed, all of the cuffs 548, 554, 558 are deflated andthe medical device 520 is pulled proximally to remove the second branchwall 532 from the bronchus. As a result, the main wall 530 and bothbranch walls 532, 534 are seated within the trachea. The camera 66 againprovides visual confirmation of the position of the medical device 520in the trachea as the carina 84 can be seen.

Once the medical device 520 is positioned completely in the trachea, thepilots 556, 560 to the inflation lines 554, 560 to the distal cuffs 554,558 are cut as shown in FIG. 37B to prevent their inflation. The maincuff 548 is then re-inflated and the medical device 520 functions as anormal endotracheal tube. This medical device 520 can be modified toinclude the camera lumen shown in FIGS. 32-35 to allow the medicalprofessional to view the tissues above or below the vocal folds 82.

This structure presents a distinct advantage over prior art double lumenendotracheal tubes. Prior art double lumen endotracheal tubes are muchwider than the present medical device 520, which may cause undue harm tothe patient.

FIGS. 38-39C show a medical device 620 which is a modified bronchoscopewhich has the camera lumen 58/window 60 and separate camera 66. Thecamera lumen 58/window 60 and separate camera 66 are like that of theprevious embodiments of the devices 20, 120, 220, 320 and the specificsare not repeated herein.

In the prior art, bronchoscopes use a fiber optic line, the position ofwhich can be manipulated by the mechanism at the proximal end of thefiber optic line. As is known in the prior art, the handle on themechanism can be toggled to cause the fiber optic line to curved eitherto the left or to the right. Prior art bronchoscopes are expensivebecause of the built-in fiber optics and if this fiber optic line iscompromised, the entire bronchoscope must be replaced.

The medical device 620 replaces the fiber optic line of the prior artbronchoscope, with an elongated plastic line 626 which is flexible, yetmaintains its rigidity. The position of the plastic line 626 ismanipulated by the same mechanism 628 which is known in the prior artbronchoscope to cause the plastic line 628 to curve to the left or tothe right (shown in FIGS. 39B and 39C) by toggling the handle 630.

The medical device 620 has the camera lumen 58/window 60 affixed to theelongated plastic line 626 by suitable means, such as ultrasonicwelding, such that the plastic line 626 and the camera lumen 58 areside-by-side. The distal ends of the plastic line 626 and the cameralumen 58 preferably terminate at the same point. As is described hereinwith respect to the other embodiments, the camera 66 is removably placedin this sealed camera lumen 58.

In use, the medical professional inserts the plastic line 626/cameralumen 58 with the camera 66 mounted therein into the patient 22 and usesit like a prior art bronchoscope. The camera 66 provides constantvisualization of the tissues of the patient 22.

The medical device 620 can be used in place of the camera lumen 58 inthe medical devices 420, 420′. 520 disclosed herein. The medical device620 can be used to place the medical devices 420, 420′, 520 in thepatient 22.

FIG. 40 shows a medical device 720 which is used to provide suction to acavity of the patient 22, such as the lungs, the chest cavity, etc. todrain fluids/air from the cavity. The medical device 720 includes acylindrical suction tube 726 which is known in the art which is attachedto the camera lumen 58/window 60 and separate camera 66. The cameralumen 58/window 60 and separate camera 66 are like that of the previousembodiments of the devices 20, 120, 220, 320, 420, 420′. 520, 620 andthe specifics are not repeated herein.

The suction tube 726 has a proximal open inlet (at the end closest tothe medical professional), an opposite distal outlet (at the endfurthest away from the medical professional during use) and a centralpassageway extending therethrough. The suction tube 726 is curved alongits length. The distal end of the suction tube 726 has a series ofperforations 728. The suction tube 726 is formed of a relatively stiffbut compliant plastics material and is preferably formed by extrusion.The proximal end of the suction tube 726 has a connector 730 attachedthereto as is known in the art. The connector 730 has two ports 732, 734which are perpendicular to each other. As is known in the art, port 732is attached to a suction device (not shown); the ribs 736 on the port732 help retain the suction device thereon. When the suction device isturned on, air will be entrained from the open port 734. The medical,professional places his/her thumb or otherwise blocks the port 734 tocause the suction tube 726 to suck fluids from the distal end throughthe perforations 728.

The camera lumen 58 is affixed, such as by ultrasonic welding, to thesuction tube 726, such that the suction tube 726 and the camera lumen 58are side-by-side. The distal ends of the suction tube 726 and the cameralumen 58 preferably terminate at the same point. As is described hereinwith respect to the other embodiments, the camera 66 is removably placedin this sealed camera lumen 58.

In use, the medical professional inserts the medical device 720 throughthe endotracheal tube 24, through a drain line (not shown) or directlyinto the patient's cavity. The camera 66 provides constant visualizationof the tissues during insertion and use of the medical device 720 intothe patient 22 and the medical professional can be assured that themedical device 720 is being properly positioned in the patient 22 withlimited trauma to the patient 22. The constant visualization of thetissues of the patient 22 can make earlier diagnoses of issues, forexample, but not limited to, secretions, tumors, paralyzed vocal folds,apnea, bleeding, and abnormal anatomy, as well as other potentiallyharmful effects to the patient 22.

The medical device 720 can be used in combination with many of the othermedical devices disclosed herein.

FIG. 41 shows a medical device 820 which provides a stylet 826 which isknown in the art which is attached to the camera lumen 58/window 60 andseparate camera 66. The camera lumen 58/window 60 and separate camera 66are like that of the previous embodiments of the devices 20, 120, 220,320, 420, 420′, 520, 620, 720 and the specifics are not repeated herein.

The camera lumen 58 is attached to the stylet 826 by suitable means,such as ultrasonic welding or a dovetail joint between the camera lumen58 and the stylet 82, such that the stylet 826 and the camera lumen 58are side-by-side. The distal ends of the stylet 826 and the camera 32lumen 58 preferably terminate at the same point. As is described hereinwith respect to the other embodiments, the camera 66 is removably placedin this sealed camera lumen 58 to continuously visualize the path thestylet 826 takes during insertion into the patient 22.

FIG. 42 shows a medical device 920 which provides a tube changer 926which is known in the art which is attached to the camera lumen58/window 60 and separate camera 66. The camera lumen 58/window 60 andseparate camera 66 are like that of the previous embodiments of thedevices 20, 120, 220, 320, 420, 420′. 520, 620, 720, 820 and thespecifics are not repeated herein.

As is known in the art, tube changers are used to change oneendotracheal tube for another endotracheal tube. The tube changer 926 isformed of an elongated, relatively stiff but compliant plastics materialand is preferably formed by extrusion. The tube changer 926 has aproximal end, a distal end and a central passageway therethrough. Theproximal end of the changer 926 is capped with a connector 930 that canbe connected to a ventilator.

The camera lumen 58 is attached to the tube changer 926 by suitablemeans, such as ultrasonic welding or a dovetail joint between the cameralumen 58 and the tube changer 926, such that the tube changer 926 andthe camera lumen 58 are side-by-side. The distal ends of the tubechanger 926 and the camera lumen 58 preferably terminate at the samepoint. As is described herein with respect to the other embodiments, thecamera 66 is removably placed in this sealed camera lumen 58 tocontinuously visualize the path the tube changer 926 takes duringinsertion into the patient 22.

In use, the medical professional feeds the medical device 920 throughthe endotracheal tube that is to be removed until the distal end of themedical device 920 is positioned proximate to the carina 84 of thepatient 22. The medical professional can see the distal end of theendotracheal tube as the camera 66 passes thereby and can see the carina84. The medical professional uses the camera 66 to constantly visualizethe tissues and to determine when the distal end of the medical device920 is proximate to the carina 84. The connector 930 is removed from themedical device 920 and the endotracheal tube is then removed from thepatient 22. If necessary, the patient 22 can be ventilated through themedical device 920 by attaching the connector 930 to the tube changer926 and attaching a ventilator to the connector 930. In order to insertthe new endotracheal tube, the connector 930 is removed from the tubechanger 926. The new endotracheal tube (which may be one of theendotracheal tube shown in FIGS. 32-37B) is fed over the medical device920 and into the trachea of the patient 22. The medical device 920 isthen pulled proximally. Once the distal end of the new endotracheal tubeis sighted using the camera 66, the medical professional must also beable to see the carina 84 to ensure that the new endotracheal tube wasnot inserted too far into the trachea (if the endotracheal tube ispositioned too deeply, the endotracheal tube can abut the carina 84, orcan be positioned in one of the bronchus of the patient 22). The newendotracheal tube can be repositioned at this time if necessary usingthe camera 66 for the proper positioning. Once the new endotracheal tubeis properly positioned, the medical device 920 is removed from the newendotracheal tube. The camera 66 can be removed from the camera lumen 58and placed into the new endotracheal tube as discussed herein.

The tube changer 926 may have graduation marks 932 thereon between theends which may be used to double check the position of the newendotracheal tube in accordance with the known Seldinger technique.Since the camera 66 provides visual confirmation of the correctplacement of the endotracheal tube, the graduations marks 932 are notnecessary.

FIGS. 43 and 44 show a medical device 1020 which is used to manipulatethe position of the epiglottis 74 of the patient 22 for intubationpurposes which is similar to a medical device commonly sold under thetrademark GLIDESCOPE®) which is owned by Verathon Medical (Canada) ULC.The medical device 1020 has a handle 1026 and curved body 1028 extendingfrom one end of the handle 1026. The handle 1026 has a finger griphandle 1030 extending therefrom at a forty-five degree angle. The fingergrip handle 1030 can be flexed relative to the handle 1026. A tip 1032is provided at the opposite end of the body 1028 and can be flexedrelative to the body 1028. A mechanism (not shown), which is known inthe art, is embedded in the medical device 1020 and connects the fingergrip handle 1030 to the tip 1032. When the medical device 1020 is heldby a medical professional, the handle 1 026 seats in the palm of themedical professional and the fingers of the medical professional wraparound the finger grip handle 1030. When the medical professionalsqueezes his/her fingers, the finger grip handle 1030 moves toward thehandle 1026 and this causes the internal mechanism to move the tip 1032toward the handle 1026. This is known in the prior art.

The prior art medical device 1020 has been modified in two respects.First, integral camera lumen 58/window 60 and LED lights 62 areprovided. The integral camera lumen 58 extends along a section of thebody 1028. The window 60 is sealed to the camera lumen 58 to prevent theentry of fluids and other matter into the camera lumen 58. This cameralumen 58 terminates at approximately the midpoint of the body 1028.Second, a disposable sleeve 1034 which conforms to the shape of the tip1032 and body 1028 is provided. The sleeve 1034 is formed of a thinplastic material. The sleeve 1034 has apertures 1036, 1038 therethroughto remove any obstruction from the view of the camera 66 and to allowthe lights 62 to shine therethrough in an unobstructed manner. Thelights 62 can be incorporated into the sleeve 1034 instead of the body1028.

In use, the camera 66 is inserted into the camera lumen 58 and thesleeve 1034 covers the tip 1032 and body 1028. The apertures 1036, 1038in the sleeve 1034 align the window 60 and the lights 62. The medicalprofessional inserts the medical device 1 020 into the mouth of thepatient 22 and the tip 1032 enters into the vallecula 110. The body 1028generally mirrors the shape of the patient's tongue 76. The sleeve 1034prevents the patient's tissues and secretions from contacting theremainder of the medical device 1020. The handle 1026 seats in the palmof the medical professional and the fingers of the medical professionalwrap around the finger grip handle 1030. The entry of the tip 1032 intothe mouth of the patient 22 is continuously visualized by the camera 66in the sealed camera lumen 58. Once the tip 1032 is properly positionedin the vallecula 110, the medical professional's fingers are squeezedand the finger grip handle 1030 moves toward the handle 1026. Thiscauses the internal mechanism in the body 1028 to move the tip 1032toward the handle 1026. The tip 1032 engages the patient's tongue 76 andpulls the tongue 76 proximally toward the outside of the mouth of thepatient 22. As a result, the epiglottis 74 is also pulled proximally tofurther open the airway of the patient 22.

With the epiglottis 74 pulled proximally, the medical professionalinserts the medical device 20, 120 or the medical device 420, 420′, 520in the patient's throat as described herein. The camera 66 can beremoved from the medical device 1020 and inserted into the medicaldevice 20, 120 or medical device 420, 420′, 520.

In all of the devices 20, 120, 220, 320, 420, 420′. 520, 620, 720, 820,920, 1020 described herein, the same camera 66 can be easily slid intoand removed from all of the sealed camera lumens 58. As a result, thecamera 66, which is an expensive component, can be used in multipledifferent devices such as those as shown (or other devices which havesuch a sealed camera lumen) by removing it from one device and insertingit into another device. Since the camera lumen 58 is sealed, it is notnecessary to sterilize the camera 66 between uses as the camera 66 doesnot come into contact with the tissues and/or secretions of the patient22.

While specific lumens (camera lumen, transmission lumen) are shown anddescribed with respect to each of the embodiments, it is to beunderstood that other lumens can also be provided each of theembodiments. Such other lumens could be used for insertion of othertools into the patient 22, for the providing oxygen to the patient 22,for suctioning fluids from the patient 22 and the like.

A transmission lumen 68 can be used in any of the devices 20, 120, 220,320, 420, 420′, 520, 620, 720, 820, 920, 1020. If such a transmissionlumen 68 is provided, a speaker (not shown) can included to audibilizethe breath and heart sounds from the patient 22 transmitted from thetransmission lumen 68. The sound from the transmission lumen 68 can bemagnified and externalized to the devices. The speaker can bedisseminated electronically. The speaker can be provided in any one ofthe lumens or tubes, or suitably connected to the lumens or tubes.

FIGS. 45 and 46 show a medical device 1120 which is allows a medicalprofessional, such as an obstetrician/gynecologist (OB/GYN), to easyview the cervix of a patient to determine the amount of dilation of thecervix. The medical device 1120 includes a cylindrical tube 1126 whichhas the camera lumen 58/window 60 attached thereto. The separate camera66 is insertable and removable from the camera lumen 58. The cameralumen 58/window 60 and separate camera 66 are like that of the previousdevices 20, 120, 220, 320, 420, 420′, 520, 620, 720, 820, and thespecifics are not repeated herein.

The tube 1126 has a proximal open inlet 1128 (at the end closest to themedical professional), an opposite distal outlet 1130 (at the endfurthest away from the medical professional during use) and a centralpassageway 1132 extending therethrough. The tube 1126 may be curvedalong its length, or it may be straight. The tube 1126 is formed of arelatively stiff but compliant plastics material and is preferablyformed by extrusion.

The camera lumen 58 is affixed, such as by ultrasonic welding, to thetube 1126, such that the tube 1126 and the camera lumen 58 areside-by-side. The camera lumen 58 can be on the external surface orexternal surface of the tube 1126. The proximal and distal ends of thetube 1126 and the camera lumen 58 preferably are at the same points. Asis described herein with respect to the other embodiments, the camera 66is removably placed in this sealed camera lumen 58. As in the previousdevices, an LED light 62 can be provided at the distal end 1130 of thetube 1132 or camera lumen 58 to illuminate the tissues, or in the camera66 itself.

In use, the medical professional inserts the medical device 1120 intothe patient's vagina such that the cervix can be seen. The camera 66provides constant visualization of the cervix and tissues duringinsertion and use of the medical device 1120 in the patient and themedical professional can be assured that the medical device 1120 isbeing properly positioned in the patient with limited trauma to thepatient. The constant visualization of the tissues of the patient canmake earlier diagnoses of issues, for example, but not limited to,secretions, tumors, bleeding, and abnormal anatomy, as well as otherpotentially harmful effects to the patient.

After the medical device 1120 is positioned, the medical professionalcan use a tool, such as the tool 1134 shown in FIG. 46, to measure theamount of dilation of the cervix. The medical device 1120 remains inplace during the labor. The camera 66 provides a constant stream ofinformation to the medical professional regarding the amount of dilationof the patient.

In any of the devices 20, 120, 220, 320, 420, 420′, 520, 620, 720, 820,920, 1020, 1120, the video information from the camera 66 and/or theinformation from the transmission lumen 68 are transmitted to amicroprocessor 82, FIG. 11, via appropriate means, such as wires,wireless, Bluetooth, etc., which in turn can transmit the information toanother computer, mobile devices, a mobile station and the like, viaappropriate means, such as wires, wireless, Bluetooth, etc., and thenthis information can be accessed by appropriate personnel. Thismicroprocessor 82 can be on-site where the procedure is being performedor can be remote from the procedure site. For example, the informationcan be supplied to the nurses' station and the nurse on duty will beable to instantly know if the patient 22 is breathing by the visualconfirmation that the vocal folds are opening and closing and by hearingbreath and heart sounds. The medical professional will be able tointerpret the depth of anesthesia by looking at the rhythmic movement ofthe vocal folds as well as other diagnoses previously mentioned. Othermedical personnel can be hundreds of miles away and still be able tomonitor, advise, confirm, and diagnose without the patient 22 being inclose physical proximity to that medical personnel. Since the camera 66is constantly operating, medical personnel can tell at any time if thepatient 22 is properly ventilated/intubated and is breathing.

In any of the devices 20, 120, 220, 320, 420, 420′, 520, 620, 720, 820,920, 1020, 1120, the LED light 62 can be provided at the distal end ofthe device 20, 120, 220, 320, 420, 420′, 520, 620, 720, 820, 920, 1020,1120, in camera lumen 58, or in the camera 66 itself to illuminate thetissues. In addition, multiple LED lights 62 can be provided in each ofthe 20, 120, 220, 320, 420, 420′, 520, 620, 720, 820, 920, 1020, 1120and can be located on different parts of the devices 20, 120, 220, 320,420, 420′, 520, 620, 720, 820, 920, 1020, 1120.

While preferred embodiments of the present invention are shown anddescribed, it is envisioned that those skilled in the art may devisevarious modifications of the present invention without departing fromthe spirit and scope of the appended claims.

1. An assembly comprising: a medical device for insertion into a cavityof a patient, said medical device comprising: a wall having a proximalend and a distal end, and a passageway extending between said proximaland distal ends; a camera lumen having a sealed window at one endthereof said camera lumen attached to said wall of said medical device,and said sealed window being proximate to said distal end of said wall;and a separate camera insertable into said camera lumen, said camerabeing removable from said camera lumen. 2-7. (canceled)
 8. The assemblyof claim 1, wherein said medical device is a suction tube for use insuctioning the cavity of the patient; said distal end of said wallhaving a series of perforations therethrough.
 9. The assembly of claim8, wherein said suction tube is curved along its length.
 10. Theassembly of claim 9, further including a connector provided at saidproximal end of said suction tube, said connector having two ports. 11.The assembly of claim 1, wherein said medical device is a bronchoscopefor use in intubating the patient.
 12. The assembly of claim 1, whereinsaid medical device is a tube changer used for changing one endotrachealtube for another endotracheal tube, said wall of said tube changerhaving graduation marks thereon.
 13. The assembly of claim 12, furtherincluding a connector attached to said proximal end of said wall, saidconnector being capable of being connected to a ventilator.
 14. Theassembly of claim 12, wherein said camera lumen is slidably connected tosaid tube changer.
 15. The assembly of claim 1, wherein said medicaldevice is a tube insertable into the vagina of a patient.
 16. Theassembly of claim 1, wherein said medical device comprises an esophagealtube for use in monitoring breath sounds of the patient, said esophagealtube formed of said wall, and a separate intubating tube connected tosaid esophageal tube, said intubating tube for use in intubating thepatient using an endotracheal tube, said intubating tube formed of awall having a passageway therethrough.
 17. The assembly of claim 16,wherein said wall of esophageal tube has first and second arcuateportions connected to each other by curved end portions, said wall ofesophageal tube having an open proximal end providing a proximal inletopening, said wall of esophageal tube having a generally conical endportion having an aperture therethrough provided at a distal end of saidwall, said passageway of esophageal tube extending through said wall ofesophageal tube and through the conical end portion, said aperture beingin communication with said passageway of esophageal tube.
 18. Theassembly of claim 16, wherein said esophageal tube is curved along itslength, and said intubating tube is curved along its length.
 19. Theassembly of claim 16, further including a slot through said wall of saidintubating tube which is in fluid communication with said passageway ofsaid intubating tube, said slot extending from a proximal end to adistal end of said wall of said intubating tube, said slot in saidintubating tube is opposite to the point of connection of saidintubating tube to said esophageal tube.
 20. (canceled)
 21. A medicaldevice for insertion into a cavity of a patient for use in determiningthe status of the internal membranes of the patient comprising: anintubating tube for use in intubating the patient using an endotrachealtube, said intubating tube formed of a body having a proximal end and adistal end, an elongated recess formed in said body having a proximalend, a distal end and a length, said recess generally extending fromsaid proximal end of said body to said distal end of said body; a sleeveconnected to said intubating tube, said sleeve being C-shaped such thatan elongated slot is formed, said sleeve being rotatable relative tosaid intubating tube, said sleeve having a length which is less than thelength of the recess; a camera lumen having a sealed window at one endthereof, said camera lumen attached to said intubating tube, said sealedwindow being positioned proximate to said distal end of said recess; aseparate camera insertable into said camera lumen, said camera beingremovable from said camera lumen.
 22. The medical device of claim 21,further including an endotracheal tube inserted within said recess. 23.The medical device of claim 21, wherein said body has a generallyconical tip at said distal end, said tip having a weight therein. 24.The medical device of claim 21, wherein said recess is curved along itslength such that in cross-section said recess is generally arcuate andforms a proximal curved ramp surface.
 25. A medical device for insertioninto a mouth of a patient for manipulating the position of theepiglottis of the patient for intubation, said medical devicecomprising: a handle having proximal and distal ends; a curved bodyextending from an end of said handle; a finger grip handle extendingfrom said handle at an angle thereto and at said proximal end of saidbody, said finger grip handle capable of being flexed relative to saidhandle; a tip provided at said distal end of said body, said tip capableof being flexed relative to said body; a camera lumen having a sealedwindow at one end thereof said camera lumen attached to said body, saidsealed window being positioned proximate to said body; and a separatecamera insertable into said camera lumen, said camera being removablefrom said camera lumen.
 26. The medical device of claim 25, furtherincluding a disposable sleeve conforming to said tip and said body, saidsleeve formed of a thin plastic material, said sleeve having aperturestherethrough.
 27. A medical device for insertion into a cavity of apatient comprising: a stylet having a proximal end and a distal end; acamera lumen having a sealed window at one end thereof said camera lumenattached to said stylet, said sealed window being positioned proximateto said distal end of said stylet; and a separate camera insertable intosaid camera lumen, said camera being removable from said camera lumen.